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EPA is seeking public comment on two proposed rules for plant-incorporated protectants (PIPs) that are based on plant viral coat protein genes (PVCP-PIPs). PVCP-PIPs are produced by plants that have been genetically engineered to contain certain genes that will protect the plant from viruses. To provide thorough and comprehensive regulatory oversight of these products, EPA is proposing a comprehensive structure to ensure these products are properly regulated based on the potential risk they may pose.

The second proposed rule that EPA is proposing is to exempt residues of the protein portion of a PVCP-PIP (the "PVC-protein") from the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 requirement to establish a food tolerance when the proteins meet certain criteria indicating they are safe for human consumption.

Comments are due to EPA 90 days after publication in the Federal Register. How to comment.

Background information

To ensure reliance on sound science in developing these proposals, EPA sought the advice of its FIFRA Scientific Advisory Panel (SAP), an independent scientific peer review body. EPA presented the SAP with a number of complex scientific issues raised by public comments and peer-reviewed publications, including a 2000 report of the National Research Council that addressed PVCP-PIPs. EPA relied heavily on the SAP's advice to develop exemption criteria to identify PVCP-PIPs that are low risk to the public. In addition, EPA sponsored or cosponsored with other Federal agencies, six conferences relevant to development of these proposed rules.

About this proposal

Any virus proteins produced by PVCP-PIPs that EPA is proposing to exempt have always been part of the food supply without adverse effects. They have no toxic effects on human or animals, and any exempt PVCP-PIPs would need to meet strict risk-based criteria to ensure they would be low risk with respect to the environment. Only those PVCP-PIPs that meet the specified criteria will be eligible for FIFRA exemption; others will require registration under FIFRA and all will require a tolerance or tolerance exemption under FFDCA. Under its Plant Protection Act authorities, the United States Department of Agriculture will continue to provide oversight of plants containing PVCP-PIPs.

The proposed rules would ensure that public health and the environment are protected while also reducing regulatory costs for PVCP-PIP developers (including pesticide manufacturers, academic researchers, and government scientists). This proposal will also clarify regulatory requirements for scientific researchers and provide important information to the public regarding the safety of exempted PVCP-PIPs.

In order to ensure proper regulatory oversight, EPA is proposing to establish three categories of oversight. For products that meet certain risk based criteria, a developer would be able to self-qualify for an exemption. For products that do not meet these criteria, EPA proposes it would review the products to determine if it qualifies for exemption. If a PVCP-PIP did not qualify for exemption under either of these processes, EPA would evaluate it under the existing registration process. More about the existing registration process.

If a developer is self-determining qualification for exemption, EPA is proposing that they must notify the Agency when they have determined that a PVCP-PIP meets all of the proposed criteria and qualifies for the FIFRA exemption. This notification would be used to record the PVCP-PIP in a database on the U.S. Regulatory Agencies Unified Biotechnology Website. This record would provide the public, including exporters, importers, and consumers, with ready access to the product's regulatory status in the United States.

The proposed exemption criteria make it unlikely that the following concerns would arise with an exempt PVCP-PIP:

The potential for increased weediness or invasiveness of the crop plant containing the PVCP-PIP or any wild or weedy relatives that could acquire the PVCP-PIP through gene flow;

The potential for viruses with novel properties to develop; or

The potential for human or non-target organism exposure to proteins that have not previously existed in nature and thus should be examined to determine whether they have potentially toxic or allergenic properties.

How to comment

Comments will be accepted until July 17, 2007. All comments should be identified by the relevant docket ID number, which EPA has established for these actions: